BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    LOCALIZATION WIRE OR MARKER - SURGICAL

    K Number: K935457 · Decision Feb 17, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    236
    Registration Numbers
    236
    Same Product Code
    27
    Applicant Total
    7
    Review Days
    97

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    Basic Information

    Device Name
    LOCALIZATION WIRE OR MARKER - SURGICAL
    K Number
    K935457
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bip USA, Inc.
    Date Received
    November 12, 1993
    Decision Date
    February 17, 1994
    Product Code
    GDF
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GDF Guide, Needle, Surgical

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